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Medical Writing
The Medical Writing group at PSI brings not only diverse backgrounds and education, but also an average of 27 years in the pharmaceutical industry. PSI’s clients receive the expertise required to meet regulatory guidelines. We offer a wide-range of writing services from protocol development to marketing authorizations and our medical writers have experience in most therapeutic areas with medical and scientific publishing. In any pharmaceutical company, Medical Writing requires intense journal research. Our PSI specialists do this for you and provide documents in succinct and accurate detail, written with quality. We publish to your specifications and standards and we can provide your deliverables in electronic or paper formats, fitting your specific study requirements.
Our medical writing team supports and can provide the following services:
- Phase I-IV Protocols
- Clinical Trial Applications ( CTA)
- Clinical Trial Documents ( CTD)
- Drug, Device and Marketing Applications
- Investigator Brochures
- Agency Briefing Documents
- DSMB Manuals
- Patient Safety Narratives
- Clinical Study Reports ( CSR)
- New Drug Applications (NDA)
- Journal Manuscripts and Abstracts
- Consulting
Our most recent experience includes the following therapeutic areas: Allergy, Dermatology, Oncology, Gastroenterology, Cardiovascular, CNS, Gynecology/Reproductive Health and Ophthalmology.